Parkinson's DiseasePhase 2NCT00125138

Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease

A Phase 2 study testing Melperone HCl in people with Parkinson's Disease and Psychotic Disorders, run by Lundbeck LLC at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. Read more about this study

Who is it for?: Any age
Conditions the study is for: Parkinson's Disease, Psychotic Disorders
What is being tested?: Melperone HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 21 sitesin 3 countries
Study dates: Jul 2005to Apr 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

The subject or subject's legally authorized representative (LAR) must sign and date the IRB/IEC approved Informed Consent Form and HIPAA Authorization (applicable to US sites only) prior to study participation.
Male or female subjects. If female:
Subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if of childbearing potential, must comply with a method of birth control acceptable to the investigator during the study, for at least one month prior to randomization and for one month following completion of the study.
Subject is not breastfeeding
Subjects of childbearing potential must have a negative serum pregnancy test at the screening visit and on Day 1.
Subjects with a clinical diagnosis of idiopathic Parkinson's Disease, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:

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Rest tremor
Rigidity
Bradykinesia and/or akinesia
Postural and gait abnormalities
Subjects with psychosis:
Presence of visual and/or auditory hallucinations, with or without delusions, occurring during the four weeks prior to the screening visit.
Symptoms severe enough to clinically warrant treatment with an antipsychotic agent.
A Hallucinations or Delusions total item score (frequency x severity) of > 4 on the Neuropsychiatric Inventory (NPI).
Subjects currently being treated with an antipsychotic agent who have not had visual and/or auditory hallucinations, with or without delusions, during the four weeks prior to screening, and/or have a Hallucinations or Delusions total item score <4 on the NPI at the screening visit may be washed out (for 7 days or 5 half-lives, whichever is longer) and return for a repeat screening visit. The NPI Hallucinations or Delusions total item score must be ≥4 at the repeat visit to be considered for study entry.
Subject is on a stable dose of anti-Parkinsonian medication(s) for at least 7 days or 5 half-lives, whichever is longer, prior to the screening visit and is expected to remain on a stable dose for the duration of the study.
Subject is willing and able to comply with all study procedures.

Who cannot join

Subject has any systemic factor contributing to the psychosis such as urinary infection, liver disease, renal failure, anemia, infection or cancer.
Subject has a history of significant psychotic disorders prior to the diagnosis of Parkinson's Disease, including but not limited to schizophrenia or bipolar disorder.
Subject has Dementia with Lewy-bodies (DLB).
Subject has dementia or a major depressive disorder precluding accurate assessment on rating scales.
Subject has an acute depressive episode at the time of the screening visit.
A score on the Mini-Mental State Examination (MMSE) of < 21.

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Subject has had a dose adjustment of their antidepressant medication within 30 days prior to the screening visit, or dose adjustments are planned during the duration of the trial.
Subject has had dose adjustments of an anxiolytic, cognitive enhancer, or other psychotropic medication (excluding antipsychotics) within 30 days prior to screening or dose adjustments are planned during the duration of the trial.
Subject has received depot antipsychotic agents within the past 3 months.
Subject has previously failed treatment with clozaril for psychosis in Parkinson's disease. Subjects who discontinued clozaril due to intolerability may be enrolled.
Subject has used any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
Subject cannot tolerate a wash-out of antipsychotic medication prior to randomization.
Subject has a history of a serious respiratory, gastrointestinal, renal, hematologic or other medical disorder.
Subject has a history of a serious cardiovascular condition (including, but not limited to, Class IV angina or Class IV heart failure) and/or a history of risk factors for Torsade de pointes (Tdp) (including but not limited to current treatment for hypokalemia or family history of long QT syndrome).
Subject had myocardial infarction within 6 months prior to screening.
Subject has a screening ECG with corrected QT interval by Bazett's correction formula (QTcB) of greater than 450 msec, if female, or 430 msec, if male.
Subject requires treatment with an α-agonist agent.
Subject has uncontrolled seizures, uncontrolled angina, or uncontrolled symptomatic orthostatic hypotension (or orthostatic hypotension leading to a history of falls 3 months prior to screening), or other medical disorders which would make the subject a poor candidate for a clinical trial.
Subject has a history of severe adverse reactions to antipsychotic medications and/or quinine.
Subject has clinically significant abnormal laboratory values, ECG, or findings on physical exam.
Subject has a recent history or current evidence of substance dependence or abuse.
Subject is unable to ingest liquid medication.
Subject is currently being treated with Deep Brain Stimulation (DBS).
Randomization Criteria
Subject has a Hallucinations or Delusions total item score (frequency x severity) of > 4 on the NPI.
Female subjects of childbearing potential must have a negative serum pregnancy test.
Subject has remained on a stable dose of anti-Parkinsonian medications.
Subject has not had a dose adjustment in their antidepressant medication since the screening visit.
Subjects have been washed out of previous antipsychotic agents for 5 half-lives or 7 days, whichever is longer, after the last dose of medication.
Subject has not had dose adjustments in an anxiolytic, cognitive enhancer or other psychotropic medication (excluding antipsychotics) since the Screening Visit.

Trial locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

United States10 sites

Quest Research Institute
Bingham Farms, Michigan, 48025
Bradenton Research Center, Inc
Bradenton, Florida, 34205
Neurology Consultants of the Carolinas
Charlotte, North Carolina, 28204
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Struthers Parkinson's Center, Park Nicollet Health Services
Golden Valley, Minnesota, 55427
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Neurology Associates
San Antonio, Texas, 78217
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Northwest Neurospecialists, PLLC
Tucson, Arizona, 85741

Other trials in United States

India8 sites

Department of Neurology, Manipal Hospital
Bangalore, Karnataka, 560017
M. S. Ramasah Memorial Hospital
Bangalore, Karnataka, 560054
KLE Hospital, Belgaum
Belagavi, Karnataka, 590 010
Apollo Hospitals Educational and Research Foundation
Chennai, Tamil Nadu, 600 006
Kasturra Medical College, Hospital, Attavar
Mangalore, Karnataka, 575 001
Jaslok Hospital and Research Center
Mumbai, Maharashtra, 400 026
SCTIMST
Trivandrum, Kerla, 695 011
Department of Neurology, Rajendra Prasad Ward, King George Hospital, Visakhapatnam
Visakhapatnam, Andhra Pradesh, 530 002

Other trials in India

Italy3 sites

Fondazione Universita di Chieti C.E.S.I. Centro Studi sull'Invecchiamento
Chieti Scalo, Ambruzzo, 66013
IRCCS Centro Neurolesi "Bonino Pulejo"
Messina, Sicily, 98124
U.O. Neurologia IRCCS San Raffaele Pisana
Rome, Lazio, 00163

Other trials in Italy

About this study

Official title: Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's Disease

Read the detailed description

Parkinson's Disease is a progressive neurodegenerative disorder characterized by bradykinesia, rigidity, tremor and abnormal posture and gait. Many patients can have mild to moderate symptoms, while others with advanced disease have symptoms which interfere with activities of daily living to a severe degree. Although effective in addressing motor dysfunction, long-term use of anti-Parkinsonian agents has been implicated as a component in the development of psychiatric side effects including psychosis. Treatment of psychosis with typical antipsychotics is not recommended in this patient population, since even low potency typical antipsychotics can cause marked exacerbations of parkinsonism in Parkinson's disease patients. The use of atypical antipsychotics (e.g., clozapine, risperidone and quetiapine) has shown some efficacy in the treatment of psychosis in PD patients. Melperone is classified atypical antipsychotic. European experience with melperone spans more than 30 years, and it encompasses an established antipsychotic efficacy profile in the treatment of confusion, anxiety, unrest (particularly in the elderly) and schizophrenia as well as a favorable safety and tolerability profile. Eligible subjects with Parkinson's disease psychosis will participate in a 1-2 week Screening/Washout Period, a 5 week Titration Phase (one of three doses of melperone or placebo), a 1 week Maintenance Phase and a Taper/Follow-up Period up to 2 weeks. Following the Day 43 assessment, subjects may be given the option of receiving melperone in an open-label extension study.

Conditions: Parkinson's Disease, Psychotic Disorders
Being tested: Melperone HCl, Placebo
Medical subject headings: Parkinson Disease, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Melperone HClDrug
20 mg/day. Strength of melperone syrup is 5 mg/mL
Melperone HClDrug
40 mg/day. Strength of melperone syrup is 5 mg/mL
Melperone HClDrug
60 mg/day. Strength of melperone syrup is 5 mg/mL
PlaceboDrug
Syrup formulation

Study groups in NCT00125138
Study group	Role	What they receive
Melperone HCl - 20 mg	Experimental	Not described Receives: Drug: Melperone HCl
Melperone HCl - 40 mg	Experimental	Not described Receives: Drug: Melperone HCl
Melperone HCl - 60 mg	Experimental	Not described Receives: Drug: Melperone HCl
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Evaluation of Symptoms of Psychosis.
The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.
Measured: 6 weeks (from Baseline to end of Maintenance Period)

Secondary outcomes (1)

Investigator/Caregiver Evaluations of Motor Function
The change in the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.
Measured: 6 weeks (from Baseline to end of Maintenance Period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Apr 2008

First posted29 Jul 2005 (estimated)
Study startJul 2005
Primary completionMar 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00125138
Sponsor's protocol ID: 13104A
Other IDs: OV1003
Status last verified: May 2011
First submitted: 27 Jul 2005
Last updated: 17 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's Disease
ClinicalTrials.gov ID: NCT00125138
Acronym / sponsor ID: 13104A
Conditions: Parkinson's Disease, Psychotic Disorders
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Lundbeck LLCIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Mar 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 29 Jul 2005 (estimated)
Results: Posted 17 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Melperone HCl - 20 mg	Experimental	Drug: Melperone HCl
Melperone HCl - 40 mg	Experimental	Drug: Melperone HCl
Melperone HCl - 60 mg	Experimental	Drug: Melperone HCl
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (17 listed)

The subject or subject's legally authorized representative (LAR) must sign and date the IRB/IEC approved Informed Consent Form and HIPAA Authorization (applicable to US sites only) prior to study participation.
Male or female subjects. If female:
Subjects with a clinical diagnosis of idiopathic Parkinson's Disease, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:
Subjects with psychosis:
Subject is on a stable dose of anti-Parkinsonian medication(s) for at least 7 days or 5 half-lives, whichever is longer, prior to the screening visit and is expected to remain on a stable dose for the duration of the study.

Key exclusion criteria (30 listed)

Subject has any systemic factor contributing to the psychosis such as urinary infection, liver disease, renal failure, anemia, infection or cancer.
Subject has a history of significant psychotic disorders prior to the diagnosis of Parkinson's Disease, including but not limited to schizophrenia or bipolar disorder.
Subject has Dementia with Lewy-bodies (DLB).
Subject has dementia or a major depressive disorder precluding accurate assessment on rating scales.
Subject has an acute depressive episode at the time of the screening visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Melperone HCl20 mg/day. Strength of melperone syrup is 5 mg/mL	Drug	Melperone HCl - 20 mg
Melperone HCl40 mg/day. Strength of melperone syrup is 5 mg/mL	Drug	Melperone HCl - 40 mg
Melperone HCl60 mg/day. Strength of melperone syrup is 5 mg/mL	Drug	Melperone HCl - 60 mg
PlaceboSyrup formulation	Drug	Placebo

Primary outcome

Patient Evaluation of Symptoms of Psychosis.
Time frame: 6 weeks (from Baseline to end of Maintenance Period)
The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.

1 secondary outcome

Investigator/Caregiver Evaluations of Motor Function
Time frame: 6 weeks (from Baseline to end of Maintenance Period)

Results and safety

Results posted to the registry on 17 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Melperone HCl - 20 mg	15	12
Melperone HCl - 40 mg	20	17
Melperone HCl - 60 mg	25	21
Placebo	30	25

Primary outcome: Patient Evaluation of Symptoms of Psychosis.

Time frame: 6 weeks (from Baseline to end of Maintenance Period). Least squares mean (Standard Error). Unit: Scores on a scale

Measure	Melperone HCl - 20 mg n = 12	Melperone HCl - 40 mg n = 17	Melperone HCl - 60 mg n = 21	Placebo n = 25
Value	-9.8 (4.4)	-12.9 (4.0)	-9.7 (3.5)	-10.0 (3.7)

Melperone HCl - 20 mg vs Placebo: Difference of LS Mean: 0.1 (95% CI -6.3 to 6.6), p = 0.5177, ANCOVA
Melperone HCl - 40 mg vs Placebo: Difference of LS mean: -2.9 (95% CI -8.5 to 2.7), p = 0.1519, ANCOVA
Melperone HCl - 60 mg vs Placebo: Difference of LS mean: 0.3 (95% CI -5.2 to 5.8), p = 0.5406, ANCOVA

Population analysed: All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat \[MITT\] population) were included in the analysis of efficacy.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were recorded from administration of study drug on Day 1 to 30 days after the last dose of study drug. SAEs were collected from when the informed consent and HIPAA (US sites only) were signed to 30 days after the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Melperone HCl - 20 mg	2 of 15 (13.3%)	6 of 15 (40%)	Not reported
Melperone HCl - 40 mg	2 of 19 (10.5%)	8 of 19 (42.1%)	Not reported
Melperone HCl - 60 mg	2 of 25 (8%)	10 of 25 (40%)	Not reported
Placebo	0 of 30 (0%)	6 of 30 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationObservational study
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Email contact via H. Lundbeck A/S study director

LundbeckClinicalTrials@lundbeck.com

21 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melperone HCl in people with Parkinson's Disease and Psychotic Disorders, run by Lundbeck LLC at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, India, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Evaluation of Symptoms of Psychosis. (time frame: 6 weeks (from Baseline to end of Maintenance Period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00125138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.